Home » Trials » SLCTR/2012/006
A study to determine the improvement of oxygenation by adopting the normal sleeping body position in individuals during artificial ventilation
-
SLCTR Registration Number
SLCTR/2012/006
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A study to determine the improvement of oxygenation by adopting the normal sleeping body position in individuals during artificial ventilation
Public Title of Trial
A study to determine the improvement of oxygenation by adopting the normal sleeping body position in individuals during artificial ventilatio
Disease or Health Condition(s) Studied
Oxygenation in ventilated patients
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC/22/2010 (Ethical Review Committee, Faculty of Medicine, University of Peradeniya)
What is the research question being addressed?
Can sleeping position influence oxygenation in ventilated patients?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
Following randomization, the following will be carried out on the intervention group: 1.Stabilization in semi recumbent position (the normal nursing position in ICU) 2.Patients placed in normal sleeping position (head and arm position) for 1 hour 3.Return to semi recumbent position
Inclusion criteria
Patients receiving mechanical ventilation in SIMV mode
Exclusion criteria
Asthma, COPD, segmental lung pathologies, chest deformities, cerebral oedema with evidence of raised intracranial pressure, clinical conditions that may contraindicate the change of position such as fractures, spinal injuries, haemodynamic instability
Primary outcome(s)
|
1.
Arterial blood gas readings |
[ At base line and at one hour after adopting the normal sleeping position ] |
|
2.
Arterial oxygen saturation |
[ At base line and at one hour after adopting the normal sleeping position ] |
|
3.
Spontaneous tidal volume |
[ At base line and at one hour after adopting the normal sleeping position ] |
|
4.
Respiratory rate |
[ At base line and at one hour after adopting the normal sleeping position ] |
Secondary outcome(s)
|
1.
Time taken to wean from the ventilator |
[ At the time of weaning from the ventilator and at the time of discharge from the ICU ] |
|
2.
Mortality at the discharge from the ICU |
[ At the time of weaning from the ventilator and at the time of discharge from the ICU ] |
Target number/sample size
174 (87 subjects per group)
Countries of recruitment
Sri Lanka
Anticipated start date
2012-08-01
Anticipated end date
2013-01-01
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2011-09-30
Approval number
2010/EC/22
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Vasanthi Pinto
Consultant Anaesthetist , Senior Lecturer
Department of Anaesthesiology, Faculty of Medicine, Peradeniya, Sri Lanka
081-2389106
0773662199
vasantipinto@yahoo.com
Contact Person for Public Queries
Dr. Vasanthi Pinto
Consultant Anaesthetist , Senior Lecturer
Department of Anaesthesiology, Faculty of Medicine, Peradeniya, Sri Lanka
081-2389106
0773662199
vasantipinto@yahoo.com
Primary study sponsor/organization
Dr. Vasanthi Pinto
Department of Anaesthesiology, Faculty of Medicine, University of Peradeniya, Sri Lanka
081-2389106, 0773662199
vasantipinto@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
